EP2475393A4 - Formulation for room temperature stabilization of a live attenuated bacterial vaccine - Google Patents

Formulation for room temperature stabilization of a live attenuated bacterial vaccine

Info

Publication number
EP2475393A4
EP2475393A4 EP20100816242 EP10816242A EP2475393A4 EP 2475393 A4 EP2475393 A4 EP 2475393A4 EP 20100816242 EP20100816242 EP 20100816242 EP 10816242 A EP10816242 A EP 10816242A EP 2475393 A4 EP2475393 A4 EP 2475393A4
Authority
EP
Grant status
Application
Patent type
Prior art keywords
attenuated
room
temperature
vaccine
stabilization
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP20100816242
Other languages
German (de)
French (fr)
Other versions
EP2475393A2 (en )
Inventor
Vu Truong-Le
Satoshi Ohtake
Gary Chiueh
Russell Martin
Atul Saxena
Binh Pham
David Lechuga-Ballesteros
Original Assignee
Vu Truong-Le
Satoshi Ohtake
Gary Chiueh
Russell Martin
Atul Saxena
Binh Pham
David Lechuga-Ballesteros
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/07Bacillus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/0208Specific bacteria not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/025Enterobacteriales, e.g. Enterobacter
    • A61K39/0275Salmonella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/025Enterobacteriales, e.g. Enterobacter
    • A61K39/0283Shigella
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/155Paramyxoviridae, e.g. parainfluenza virus
    • A61K39/165Mumps or measles virus
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/522Bacterial cells; Fungal cells; Protozoal cells avirulent or attenuated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/52Bacterial cells; Fungal cells; Protozoal cells
    • A61K2039/523Bacterial cells; Fungal cells; Protozoal cells expressing foreign proteins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525Virus
    • A61K2039/5254Virus avirulent or attenuated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55561CpG containing adjuvants; Oligonucleotide containing adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA Viruses negative-sense
    • C12N2760/00011MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA Viruses negative-sense ssRNA Viruses negative-sense
    • C12N2760/18011Paramyxoviridae
    • C12N2760/18411Morbillivirus, e.g. Measles virus, canine distemper
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA Viruses negative-sense
    • C12N2760/00011MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA Viruses negative-sense ssRNA Viruses negative-sense
    • C12N2760/18011Paramyxoviridae
    • C12N2760/18411Morbillivirus, e.g. Measles virus, canine distemper
    • C12N2760/18434Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA Viruses negative-sense
    • C12N2760/00011MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA Viruses negative-sense ssRNA Viruses negative-sense
    • C12N2760/18011Paramyxoviridae
    • C12N2760/18411Morbillivirus, e.g. Measles virus, canine distemper
    • C12N2760/18451Methods of production or purification of viral material
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
    • Y02A50/46Medical treatment of waterborne diseases characterized by the agent
    • Y02A50/468The waterborne disease being caused by a bacteria
    • Y02A50/475The waterborne disease being caused by a bacteria of the genus Shigella, i.e. Dysentery
    • Y02A50/476The waterborne disease being caused by a bacteria of the genus Shigella, i.e. Dysentery the medicinal preparation containing antigens or antibodies, e.g. vaccines, antisera
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
    • Y02A50/46Medical treatment of waterborne diseases characterized by the agent
    • Y02A50/468The waterborne disease being caused by a bacteria
    • Y02A50/481The waterborne disease being caused by a bacteria of the genus Salmonella, i.e. Salmonellosis
    • Y02A50/482The waterborne disease being caused by a bacteria of the genus Salmonella, i.e. Salmonellosis the medicinal preparation containing antigens or antibodies, e.g. vaccines, antisera
EP20100816242 2009-09-13 2010-09-13 Formulation for room temperature stabilization of a live attenuated bacterial vaccine Withdrawn EP2475393A4 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US24237609 true 2009-09-14 2009-09-14
PCT/US2010/048674 WO2011032108A3 (en) 2009-09-13 2010-09-13 Formulation for room temperature stabilization of a live attenuated bacterial vaccine
US12880213 US20110064723A1 (en) 2009-09-14 2010-09-13 Formulation for room temperature stabilization of a live attenuated bacterial vaccine

Publications (2)

Publication Number Publication Date
EP2475393A2 true EP2475393A2 (en) 2012-07-18
EP2475393A4 true true EP2475393A4 (en) 2013-08-21

Family

ID=43730797

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20100816242 Withdrawn EP2475393A4 (en) 2009-09-13 2010-09-13 Formulation for room temperature stabilization of a live attenuated bacterial vaccine

Country Status (3)

Country Link
US (1) US20110064723A1 (en)
EP (1) EP2475393A4 (en)
WO (1) WO2011032108A3 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102755642B (en) * 2012-07-13 2014-01-08 中国食品药品检定研究院 Preparing method of anthrax vaccines
CA2913971A1 (en) * 2013-05-31 2014-12-04 Universal Stabilization Technologies, Inc. Polymeric compositions containing ambient-temperature stable biopharmaceuticals & methods for formulation thereof
EP3049108A2 (en) 2013-09-27 2016-08-03 Intervet International B.V. Dry formulations of vaccines that are room temperature stable
CA2926696A1 (en) * 2013-10-16 2015-04-23 Merck Sharp & Dohme Corp Thermostable respiratory synctial virus (rsv) vaccine compositions

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030219475A1 (en) * 2002-04-11 2003-11-27 Medlmmune Vaccines, Inc. Preservation of bioactive materials by freeze dried foam
US20080229609A1 (en) * 2004-06-02 2008-09-25 Victor Bronshtein Preservation by Vaporization

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100120014A1 (en) * 2002-06-18 2010-05-13 Victor Bronshtein Stability Drying
US5766520A (en) * 1996-07-15 1998-06-16 Universal Preservation Technologies, Inc. Preservation by foam formation
US6692695B1 (en) * 1999-05-06 2004-02-17 Quadrant Drug Delivery Limited Industrial scale barrier technology for preservation of sensitive biological materials
US6306345B1 (en) * 1998-05-06 2001-10-23 Universal Preservation Technologies, Inc. Industrial scale barrier technology for preservation of sensitive biological materials at ambient temperatures
US7153472B1 (en) * 2000-11-22 2006-12-26 Quadrant Drug Delivery Limited Preservation and formulation of bioactive materials for storage and delivery in hydrophobic carriers
US7101693B2 (en) * 2001-09-07 2006-09-05 Brigham Young University Plasticized hydrophilic glasses for improved stabilization of biological agents
US6884866B2 (en) * 2001-10-19 2005-04-26 Avant Immunotherapeutics, Inc. Bulk drying and the effects of inducing bubble nucleation
US6904701B2 (en) * 2002-02-15 2005-06-14 The Regents Of The University Of California Flask and method for drying biological materials
CA2503946C (en) * 2002-11-01 2016-08-16 Glaxosmithkline Biologicals S.A. Drying process

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030219475A1 (en) * 2002-04-11 2003-11-27 Medlmmune Vaccines, Inc. Preservation of bioactive materials by freeze dried foam
US20080229609A1 (en) * 2004-06-02 2008-09-25 Victor Bronshtein Preservation by Vaporization

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
AHMAD M ABDUL-FATTAH ET AL: "Drying-Induced Variations in Physico-Chemical Properties of Amorphous Pharmaceuticals and Their Impact on Stability II: Stability of a Vaccine", PHARMACEUTICAL RESEARCH, KLUWER ACADEMIC PUBLISHERS-PLENUM PUBLISHERS, NL, vol. 24, no. 4, 15 February 2007 (2007-02-15), pages 715 - 727, XP019483503, ISSN: 1573-904X, DOI: 10.1007/S11095-006-9191-2 *
ANNEAR D. I.: "Recoveries of bacteria after drying and heating in glutamate foams", JOURNAL OF HYGIENE, vol. 68, no. 3, 1 January 1970 (1970-01-01), pages 457 - 459, XP009171161 *
YUHONG ZENG: "Towards development of stable formulations of a live attenuated bacterial vaccine", 1 May 2009 (2009-05-01), pages 322 - 331, XP055071143, Retrieved from the Internet <URL:http://www.landesbioscience.com/journals/vaccines/article/7559/ZengHV5-5.pdf> [retrieved on 20130712] *

Also Published As

Publication number Publication date Type
WO2011032108A2 (en) 2011-03-17 application
EP2475393A2 (en) 2012-07-18 application
US20110064723A1 (en) 2011-03-17 application
WO2011032108A3 (en) 2012-11-29 application

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